VNDA

HETLIOZ® (tasimelteon)

Smith-Magenis Syndrome (SMS)

PDUFA

Exp Date

December 1, 2020

Amp Volatility Score

Catalyst Info & Data Links

TITLE: HETLIOZ® (tasimelteon) for Smith-Magenis Syndrome (SMS) - PDUFA

  • ClinicalTrial.gov (NCT02776215) Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents

  • ClinicalTrial.gov (NCT02231008) Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS


WHAT IS THE NEXT CATALYST EVENT?

  • PDUFA


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?


PRIOR DATA

PRESS RELEASES

MARKET

  • Smith-Magenis syndrome affects at least 1 in 25,000 individuals worldwide. 

  • Learn more - U.S. National Library of Medicine

MECHANISM OF ACTION / RATIONALE

  • The precise mechanism by which tasimelteon exerts its therapeutic effect in patients with Non- 24 is not known. Tasimelteon is an agonist at melatonin MT1 and MT2 receptors. These receptors are thought to be involved in the control of circadian rhythms (learn more pg 6). 

Updated by HC

#VNDA, #HETLIOZ®, #tasimelteon, #Smith_Magenis_Syndrome, #SMS

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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